Title: STAND ARD OPERATING PROCEDURE

Document: Effective Date:

SOP_QA_ rev.__ dd.mm.yyyy.

PRODUCT RECALL
Applicable to Departments: SAL, QA, MA, RE, WH

Page: 1 of 3

Table of Contents: 1. Purpose .................................................................................................................................................. 2. Scope...................................................................................................................................................... 3. Responsibilities ...................................................................................................................................... 4. Definitions and abbreviations ................................................................................................................ 5. Procedure ............................................................................................................................................... 6. Reviosion Hystory ................................................................................................................................

2 2 2 2 3 5

1.

Purpose
This procedure specifies the responsibilities and the system for product recall from the market, as required, to prevent unacceptable quality products to reach the customers (patients). This SOP also specifies, pursuant to the Medicines Law, the way of notification of all stakeholders by the relevant departments of the decision made to recall an already marketed product.

2.

Scope
This SOP is applicable to all authorized and marketed products for which there is an evidence or potential that:

The product is noncompliant with the Marketing Authorization and, therefore, can have undesirable effects to the patients health. The reputation of the Company can be severely compromised.

3.

Responsibilities
QA Manager is responsible for the implementation of this SOP. Other responsibilities are specified by sequence of activities and job descriptions.

4.
4.1

Definitions
Distribution network Distribution route of the product from leaving the Company premises to arrival to different wholesalers, health centers, and hospital and public pharmacies.

4.2

Product recall Product recall from the market includes the overall action is undertaking in case of recall of one or several product batches from the market with the objective to protect the patients from inappropriate product which could have adverse effects and compromise their health.

4.3

Recall notification Written information sent to all companies, institutions or individual customers to whom the recalled product has been supplied.

4.4

Official recall notification The official notification of product recall to the Ministry of Health shall be made when the product noncompliance is of the nature that could compromise public health.

5.

Procedure
A product is recalled from the market based on: Complaint from the market;

Title: STAND ARD OPERATING PROCEDURE

Document: Effective Date:

SOP_QA_ rev.__ dd.mm.yyyy.

PRODUCT RECALL
Applicable to Departments: SAL, QA, MA, RE, WH

Page: 2 of 3

5.1

Recall order issued by the national inspection authorities; Deviation from the specified quality is discovered after the product was distributed on the market; Labeling error; When the product is denied Marketing Authorization.

Investigation and Actions A product can be recalled for the following reasons: Mistake in the manufacturing or packaging process, discovered after the product was released on the market; Product testing or release mistakes discovered after the product was released on the market; Unacceptable stability test results; Frequent customer complaints on the product quality; Serious warning of the medicinal product safety obtained after reviewing PSUR unexpected undesirable events or a known undesirable event occurring with increased frequency.

When, for any of the above reason, a need is identified for product recall from the market, the team consisting of the QA Manager, Sales and Regulatory Affairs Managers shall, based on the available documentation on the product batch in question, assess the emergency and the establish the recall scope. The team shall specify the strategy to be used for recalling only part or the whole product batch or several batches (time frame for recall execution, institutions to be notified of the recall, and collecting the product distribution data). If required, the team shall specify the action to be taken for release of information to public and define contact with the media to avoid negative publicity. They shall relate to the Finance Division to identify the resources required for recalling the product and discuss its cost effects. This decision shall be documented on the form Product Recall Decision Sales Manager shall coordinate the contact with customers and report recall action progress. 5.2 Identifying distribution sites The Sales Manager shall, together with the wholesalers warehouse, establish the product stock status in the warehouse and at any site to which the recalled product was distributed, the exact quantities of the product and supply dates. The Sales associate/administrative officer shall produce the customer list including their addresses, telephone numbers and contact persons, as well as the supplied quantities and submit it to the Sales Manager. 5.3 5.4 Recall notification The recall team shall prepare a recall notification in writing on the Company Memorandum. Distribution of the recall notification The QA Manager shall, depending on the assessed emergency, submit the recall notification to the Ministry of Health, to all listed customers, and/or media (if the reason for recall is of the nature that can compromise public health). 5.5 Product recall On the basis of agreed action, the Sales Manager shall, together with the Shipping Department, arrange for collecting the recalled product from the market. The product from individual customers shall be collected by the field operators who shall prepare written reports on the product quantity collected from each customer and make the reconciliation of the supplied and collected quantities.

Title: STAND ARD OPERATING PROCEDURE

Document: Effective Date:

SOP_QA_ rev.__ dd.mm.yyyy.

PRODUCT RECALL
Applicable to Departments: SAL, QA, MA, RE, WH

Page: 3 of 3

The Sales Manager shall coordinate product recall from the market; monitor the recall action and report of the recall progress. 5.6 Recalled products storage The warehouse shall receive the recalled products and keep the records of the arrived quantities. The collected recalled products shall be stored in a segregated area and appropriately labeled with the inscription PRODUCT RECALLED FROM THE MARKET, where they will be waiting for disposal. 5.7 Recall Final report The Sales Manager shall, with other team members, prepare the final report on all actions taken for product recall from the market including the recalled quantity, and submit it to the Top Management. This Final Report shall also be submitted to the Ministry of Health. 5.8 Recalled product log Based on the Final Recall Report, the QA Manager shall keep the recalled product log using the form Recalled Products Log The recalled products report shall be prepared periodically and distributed to the Top Management. 5.9 Archiving All relevant documents (Recall Decision, Recall Notification, Product Distribution List, and Field Reports on Product Recall) shall be kept with the Sales Department for 6 years Recalled Product Log shall be kept with QA 6 years. 6. Revision History

Revision No. Description of Change 00 01 Basic document Change of SOP code and minor changes in the text

End of document